1/19/2018
Noninvasive Fractional Flow Reserve Measurement
Date Printed: January 19, 2018: 05:29 PM
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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You
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document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be
sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright
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The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a
trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation
of one product over another, and is not intended to represent a complete listing of all products available.
04-78000-22
Original Effective Date: 12/15/17
Reviewed : 12/08/17
Revised : 00/00/00
Subject: Noninvasive Fractional Flow Reserve Measurement
THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR
A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL
DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE
GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE
TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS
UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.
Position Statement
Billing/Coding
Reimbursement
Program Exceptions
Definitions
Related Guidelines
Other
References
Updates
DESCRIPTION:
Fractional flow reserve (FFR) derived by standard acquired coronary computed tomography angiography (FFRCT) enables
computational assessment of coronary blood flow and pressure. Noninvasive calculation of FFR from coronary computed
tomographic (FFRCT) applies computational fluid dynamics to determine the physiologic significance of coronary artery disease
(CAD). Coronary physiology is a tool that can guide management decisions for intermediate lesions and multivessel coronary artery
disease (CAD), determine whether the patient would benefit from coronary revascularization or medical therapy (Jesen et al. 2017,
Min et al. 2012, Shlofmitz et al. 2017).
Fractional flow reserve (FFR) is the ratio of maximal blood flow in a stenotic artery to normal maximal flow. FFR is easily measured
during coronary angiography by using a pressure guidewire to calculate the ratio of distal coronary pressure to aortic pressure. FFR
in a normal coronary artery equals 1.0. An FFR value of 0.80 or less identifies ischemia-causing coronary stenosis with an accuracy
of more than 90% (Tonino et al. 2009).
The HeartFlow fractional flow reserve (FFRCT); FFRCT v.1.4 simulation software was cleared for marketing by the U.S. Food and
Drug Administration (FDA) through the de novo 510(k) process (Nov 2014) and the FFRCT v2.0 device was cleared through a
subsequent 510(k) process (Jan 2016). The HeartFlow FFRCT is classified as a coronary physiologic simulation software device.
HeartFlow FFRCT is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously
acquired Computed Tomography *DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides
FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a
3D computer model generated from static coronary CT images. FFRCT analysis is intended to support the functional evaluation of
coronary artery disease (FDA, 2017).
* Digital Imaging and Communications in Medicine (DICOM)
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POSITION STATEMENT:
The use of noninvasive fractional flow reserve following a positive coronary computed tomography angiography meets the
definition of medical necessity to guide decisions about the use of invasive coronary angiography in members with stable chest
pain at intermediate risk of coronary artery disease (i.e., suspected or presumed stable ischemic heart disease).
The use of noninvasive fractional flow reserve for all other indications when the above criteria are not met is considered
experimental or investigational. The evidence is insufficient to determine that noninvasive fractional flow reserve results in
improvement in net health outcome.
BILLING/CODING INFORMATION:
CPT Coding:
0501T
Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography
angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to
assess the severity of coronary artery disease; data preparation and transmission, analysis of fluid dynamics and
simulated maximal coronary hyperemia, generation of estimated FFR model, with anatomical data review in
comparison with estimated FFR model to reconcile discordant data, interpretation and report
0502T
Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography
angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to
assess the severity of coronary artery disease; data preparation and transmission, analysis of fluid dynamics and
simulated maximal coronary hyperemia, generation of estimated FFR model, with anatomical data review in
comparison with estimated FFR model to reconcile discordant data, data preparation and transmission
0503T
Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography
angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to
assess the severity of coronary artery disease; data preparation and transmission, analysis of fluid dynamics and
simulated maximal coronary hyperemia, generation of estimated FFR model, with anatomical data review in
comparison with estimated FFR model to reconcile discordant data, analysis of fluid dynamics and simulated
maximal coronary hyperemia, and generation of estimated FFR model
0504T
Noninvasive estimated coronary fractional flow reserve (FFR) derived from coronary computed tomography
angiography data using computation fluid dynamics physiologic simulation software analysis of functional data to
assess the severity of coronary artery disease; data preparation and transmission, analysis of fluid dynamics and
simulated maximal coronary hyperemia, generation of estimated FFR model, with anatomical data review in
comparison with estimated FFR model to reconcile discordant data, anatomical data review in comparison with
estimated FFR model to reconcile discordant data, interpretation and report
ICD-10 Diagnosis Codes That Support Medical Necessity:
I20.9
Angina pectoris, unspecified
I25.118
Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris
I25.119
Atherosclerotic heart disease of native coronary artery with unspecified angina pectoris
REIMBURSEMENT INFORMATION:
Refer to section entitled POSITION STATEMENT.
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Determination of Pretest Probability for Coronary Artery Disease (CAD)
Table 1: Determination of Pretest Probability for Coronary Artery Disease Based on Age, Gender, and Symptoms (Source:
American College of Cardiology Criteria for Pretest Probability of Coronary Artery Disease (CAD)).
The following risk assessment may be used to determine pre-test probability of coronary artery disease.
Table 1:
Age (years)
Gender
Typical/Definite
Atypical/Probable
Nonanginal Chest
Asymptomatic
Angina Pectoris
Angina Pectoris
Pain
30 - 39
Men
Intermediate
Intermediate
Low
Very low
Women
Intermediate
Very low
Very low
Very low
40 - 49
Men
High
Intermediate
Intermediate
Low
Women
Intermediate
Low
Very low
Very low
50 - 59
Men
High
Intermediate
Intermediate
Low
Women
Intermediate
Intermediate
Low
Very low
60 - 69
Men
High
Intermediate
Intermediate
Low
Women
High
Intermediate
Intermediate
Low
High: Greater than 90% pre-
Intermediate: Between 10%
Low: Between 5% and 10% pre-
Very low: Less than 5% pre-
test probability of CAD
and 90% pre-test probability of
test probability of CAD
test probability of CAD
CAD
Angina: As defined by the American College of Cardiology (ACC)/American Heart Association (AHA)
Typical Angina (Definite): 1.) Substernal chest pain or discomfort that is 2.) Provoked by exertion or emotional stress and 3.)
Relieved by rest and/or nitroglycerine.
Atypical Angina (Probable): Chest pain or discomfort that lacks one of the characteristics of definite or typical angina.
Non-Anginal Chest Pain: Chest pain or discomfort that meets one or none of the typical angina characteristics.
Framingham Risk Assessment for Coronary Heart Disease (CHD) Risk
Table 2: Framingham Risk Assessment for Coronary Heart Disease (CHD) Risk
Framingham risk assessment is a calculation to predict the 10-year risk of heart disease. The calculation is based on the
individual’s age, sex, most recent lipid values, blood pressure, smoking history, and presence of diabetes.
Table 2:
CHD Risk Level
Framingham Score
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CHD Risk-Low Defined by the age-specific risk level that is below average. In general, low risk will
Less than 10%
correlate with a 10-year absolute CHD risk.
CHD Risk-Moderate Defined by the age-specific risk level that is average or above average.
Between 10% and 20%
CHD Risk-High Defined as the presence of diabetes mellitus.
Greater than 20%
Duke Treadmill Score
The equation for calculating the Duke treadmill score (DTS) is, DTS = exercise time in minutes - (5 * ST deviation in mm or 0.1 mV
increments) - (4 * exercise angina score), with angina score being 0 = none, 1 = non limiting, and 2 = exercise-limiting. The score
typically ranges from -25 to +15. These values correspond to low-risk (with a score of >/= +5), intermediate risk (with scores ranging
from - 10 to + 4), and high-risk (with a score of </= -11) categories.
Online cardiac risk calculator and assessment tools:
The links for the online cardiac risk calculator and assessment tools are to an outside source and is provided for your convenience.
Use of the links and related calculator and assessment tools are subject to the terms and conditions of the website and is not
warranted, maintained or affiliated with Florida Blue.
Framingham Risk Score Calculator
Reynolds Risk Score
Pooled Cohort Risk Assessment Equations
PROGRAM EXCEPTIONS:
Federal Employee Program (FEP): Follow FEP guidelines.
State Account Organization (SAO): Follow SAO guidelines.
Medicare Advantage products:
No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) was found at the time of the last guideline
reviewed date.
DEFINITIONS:
No guideline specific definitions apply.
RELATED GUIDELINES:
None applicable.
OTHER:
NOTE: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another,
and is not intended to represent a complete listing of all products available.
REFERENCES:
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downstream clinical event rate. Clinical Imaging. 2016 Sep-Oct;40(5):1055-1060.
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Noninvasive Fractional Flow Reserve Measurement
2. Blue Cross an d Blue Shield Association Technology Evaluation Center (TEC). Fractional flow reserve and coronary artery
revascularization. TEC Assessments. 2011; Volume 26: No. 2.
3. Blue Cross and Blue Shield Association Medical Policy Reference Manual Coronary computed tomography angiography
with selective noinvasive fractional flow reserve 6.01.59, 06/17.
4. Bundhun PK, Yanamala CM, Huang F. Comparing the adverse clinical outcomes associated with fraction flow reserve-
guided versus angiography-guided percutaneous coronary intervention: a systematic review and meta-analysis of
randomized controlled trials. BMC Cardiovascular Disorders. 2016 Dec 3;16 (1):249.
5. Chinnaiyan KM, Akasaka T, Amano T et al. Rationale, design and goals of the HeartFlow assessing diagnostic value of
non-invasive FFRCT in Coronary Care (ADVANCE) registry. Journal of Cardiovascular Computed Tomography. 2017 Jan -
Feb;11(1):62-67.
6. Christou MA, Siontis GC, Katritsis DG et al. Meta-analysis of fractional flow reserve versus quantitative coronary
angiography and noninvasive imaging for evaluation of myocardial ischemia. American Journal of Cardiology 2007 Feb
15;99(4):450-456.
7. Coenen A, Lubbers MM, Kurata A et al. Fractional flow reserve computed from noninvasive CT angiography data:
diagnostic performance of an on-site clinician-operated computational fluid dynamics algorithm. Radiology. 2015
Mar;274(3):674-683.
8. Colleran R, Douglas PS, Hadamitzky M et al. An FFRCT diagnostic strategy versus usual care in patients with suspected
coronary artery disease planned for invasive coronary angiography at German sites: one-year results of a subgroup
analysis of the PLATFORM (Prospective Longitudinal Trial of FFRCT: Outcome and Resource Impacts) study. Open Heart
2017 Mar 22; 4(1):e000526.
9. Danad I, Szymonifka J, Twisk JWR et al. Diagnostic performance of cardiac imaging methods to diagnose ischaemia-
causing coronary artery disease when directly compared with fractional flow reserve as a reference standard: a meta-
analysis. European Heart Journal 2017 Apr 1;38(13):991-998.
10. De Bruyne B, Fearon WF, Pijls NH et al. Fractional flow reserve-guided PCI for stable coronary artery disease. New
England Journal of Medicine 2014 Sep 25;371(13):1208-1217.
11. De Bruyne B, Pijls NH, Kalesan B et al. Fractional flow reserve-guided PCI versus medical therapy in stable coronary
disease. New England Journal of Medicine 2012 Sep 13;367(11):991-1001.
12. Dewey M, Rief M, Martus P et al. Evaluation of computed tomography in patients with atypical angina or chest pain
clinically referred for invasive coronary angiography: randomised controlled trial. British Medical Journal 2016 Oct
24;355:i5441.
13. Douglas PS, De Bruyne B, Pontone G et al. 1-Year outcomes of FFRCT-guided care in patients with suspected coronary
disease: the PLATFORM study. Journal of the American College of Cardiology 2016 Aug 2; 435-445.
14. Douglas PS, Hoffmann U, Lee KL et al. PROspective multicenter imaging study for evaluation of chest pain: rationale and
design of the PROMISE trial. American Heart Journal 2014 Jun;167(6):796-803.e1.
15. Douglas PS, Pontone G, Hlatky MA et al. Clinical outcomes of fractional flow reserve by computed tomographic
angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective
longitudinal trial of FFR (CT): outcome and resource impacts study. European Heart Journal. 2015 Dec 14;36(47):3359-67.
16. Food and Drug Administration (FDA) 510(k) Approval FFRCT v 2.0/Coronary Physiologic Simulation Software Device
(HeartFlow, Inc.) K161772, 2016.
17. Gaur S, Achenbach S, Leipsic J et al. Rationale and design of the HeartFlowNXT (heartflow analysis of coronary blood flow
using CT angiography: NeXt sTeps) study. Journal of Cardiovascular Computed Tomography 2013 sept-Oct; 7(5): 279-288.
18. Gaur S, Ovrehus KA, De D, et al. Coronary plaque quantification and fractional flow reserve by coronary computed
tomography angiography identify ischaemia-causing lesions. European Heart Journal 2016; 37, 1220-1227.
19. Hendel RC, Patel MR, Kramer CM et al. ACCF/ACR/SCCT/SCMR/ ASNC/NASCI/SCAI/SIR 2006 Appropriateness Criteria
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of Radiology, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance,
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20. Jensen JM, Botker HE, Mathiassen ON et al. Computed tomography derived fractional flow reserve testing in stable
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Sept 26, 2012: 308(12): 1245-1237.
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27. Morris PD, van de Vosse FN, Lawford PV et al. “Virtual” (computed) fractional flow reserve: current challenges and
limitations. JACC Cardiovasc Interventions. 2015 Jul; 8(8): 1009-1017.
28. Nakanishi R, Budoff MJ. Noninvasive FFR derived from coronary CT angiography in the management of coronary artery
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29. Nakazato R, Park HB, Berman DS et al. Noninvasive fractional flow reserve derived from computed tomography
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30. National Institute for Health and Care Excellence. HeartFlow FFRCT for estimating fractional flow reserve from
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33. Pijls NH, De Bruyne B, Peels K et al. Measurement of fractional flow reserve to assess the functional severity of coronary-
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COMMITTEE APPROVAL:
This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 12/08/17.
GUIDELINE UPDATE INFORMATION:
01/01/18
New Medical Coverage Guideline.
Date Printed: January 19, 2018: 05:29 PM
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